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KYSA-8: A Phase 2 Open-Label, Single-Arm, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome

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Trial Profile

KYSA-8: A Phase 2 Open-Label, Single-Arm, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Aug 2026

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At a glance

  • Drugs Mivocabtagene autoleucel (Primary)
  • Indications Neuroinflammatory disorders; Stiff-person syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms KYSA-8

Most Recent Events

  • 11 Aug 2026 According to Kyverna Therapeutics media release, The Company plans to report 12-month topline data from KYSA-8 in Q3 2026.
  • 11 Aug 2026 According to Kyverna Therapeutics media release, the company plans to seek priority review, under the Regenerative Medicine Advancedtherapy (RMAT) designation, positioning miv-cel for potential commercial launch in 2027.
  • 11 Aug 2026 According to Kyverna Therapeutics media release, the company has initiated its rolling BLA, submitted the Chemistry, Manufacturing andControls (CMC) module and is on track to complete its submission in the fourth quarter of 2026.

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